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Intergovernmental Data Quality Task Force Uniform Federal Policy for Quality Assurance Project Plans Optimized UFP-QAPP Worksheets March 2012

Optimized UFP-QAPP Worksheets (PDF)

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Page 1: Optimized UFP-QAPP Worksheets (PDF)

Intergovernmental Data Quality Task Force

Uniform Federal Policy for

Quality Assurance Project Plans

Optimized UFP-QAPP Worksheets

March 2012

Page 2: Optimized UFP-QAPP Worksheets (PDF)

List of QAPP Worksheets

#1 & 2: Title and Approval Page

#3 & 5: Project Organization and QAPP Distribution

#4, 7 & 8: Personnel Qualifications and Sign-off Sheet

#6: Communication Pathways

#9: Project Planning Session Summary

#10: Conceptual Site Model

#11: Project/Data Quality Objectives

#12: Measurement Performance Criteria

#13: Secondary Data Uses and Limitations

#14/16: Project Tasks & Schedule

#15: Project Action Limits and Laboratory-Specific Detection/Quantitation Limits

#17: Sampling Design and Rationale

#18: Sampling Locations and Methods

#19 & 30: Sample Containers, Preservation, and Hold Times

#20: Field QC Summary

#21: Field SOPs

#22: Field Equipment Calibration, Maintenance, Testing, and Inspection

#23: Analytical SOP’s

#24: Analytical Instrument Calibration

#25: Analytical Instrument and Equipment Maintenance, Testing, and Inspection

#26 & 27: Sample Handling, Custody, and Disposal

#28: Analytical Quality Control and Corrective Action

#29: Project Documents and Records

#31, 32 & 33: Assessments and Corrective Action

#34: Data Verification and Validation Inputs

#35: Data Verification Procedures

#36: Data Validation Procedures

#37: Data Usability Assessment

Page 3: Optimized UFP-QAPP Worksheets (PDF)

Executive Summary

The Uniform Federal Policy for Quality Assurance Project Plans (UFP-QAPP) is a consensus quality systems document prepared by the Intergovernmental Data Quality Task Force (IDQTF), a working group made up of representatives from the U.S. Environmental Protection Agency (EPA), the Department of Defense (DoD), and the Department of Energy (DOE). Originally issued in 2005, the UFP-QAPP was developed to provide procedures and guidance for consistently implementing the national consensus standard ANSI/ASQ E-4, Quality Systems for Environmental Data and Technology Programs, for the collection and use of environmental data at Federal facilities.

The UFP-QAPP consists of the following parts:

Part 1: UFP-QAPP Manual – general guidance and instructions for preparing QAPPs Part 2A: UFP-QAPP Workbook – a collection of templates or worksheets that, once completed, addresses all required elements of a QAPP Part 2B: UFP-QAPP Compendium – specifications for minimum quality assurance (QA) and quality control (QC) activities for hazardous waste projects Part 2C: Example QAPPs – documents illustrating the implementation of the UFP-QAPP and use of the worksheets for different types of projects in a graded approach

This document represents the first revision to Part 2A: The UFP-QAPP Workbook. The original workbook consisted of 37 worksheets or templates, designed to facilitate the preparation of QAPPs. By walking the project team and other stakeholders through a systematic planning process, the worksheets were designed to help focus data collection on the specific decisions to be made so that the type, quality, and quantity of data to be collected would be suitable for their intended uses and agreed upon before data collection began.

Although use of the UFP-QAPP workbook has streamlined the preparation and review of QAPPs over the past several years, it has also revealed opportunities for improvement. In 2010, the IDQTF established a subgroup to make recommendations for optimizing the worksheets. The optimization effort was performed with the following objectives:

1. Eliminate redundancy of information contained in certain worksheets; 2. Increase the ease of worksheet population, review, and use; 3. Clarify and promote the use of the systematic planning process and the implementation of a

graded approach; and 4. Promote consistency in the use of QA/QC terminology and procedures among the Federal

agencies.

Overview of Part 2A, Revision 1 The optimization of the UFP-QAPP worksheets was performed in close coordination with EPA’s update of QA/G5, Guidance for Quality Assurance Project Plans, which has been superseded by (CIO 2106-G-05 QAPP, September 2011), to promote greater consistency between the two documents. While use of the term QAPP has been retained, the information contained in the worksheets continues to capture the elements that would comprise related project-planning documents, such as a Sampling and Analysis Plan (SAP), Work Plan (WP), and Field Sampling Plan (FSP).

Page 4: Optimized UFP-QAPP Worksheets (PDF)

The preparation of Revision 1 involved the consolidation of several worksheets into a final product containing 27 worksheets. For ease of reference, the revised worksheets are named to reflect the original worksheets on which they are based. Instructions for completing the worksheets are contained in green text. Examples are provided in blue text. Examples are for illustration purposes only and should not be construed to establish acceptable standards for any purpose.

The remaining parts of the original UFP-QAPP manual have not been updated but may still be used as aids to the development of QAPPs. The IDQTF is in the process of preparing enhanced instructions and supplemental guidance to aid in the preparation of QAPPs.

Scope and Applicability

The UFP-QAPP Workbook, Revision 1 is a tool to guide project teams through the systematic planning process. Although designed for use in support of hazardous waste programs (CERCLA and RCRA) at Federal facilities, use of the UFP-QAPP is applicable to any environmental program for which data will be collected and analyzed, and worksheets may be customized accordingly. Examples of customized applications include the development of QAPPS for compliance testing conducted in accordance with the Clean Water Act (CWA) and environmental investigations conducted in accordance with the Military Munitions Response Program (MMRP). Project teams are encouraged to use the graded approach when developing QAPPS, giving appropriate consideration to the significance of the environmental problems to be investigated, the types of environmental decisions to be made, the impact on human health and the environment, and available resources.

The optimized worksheets address all requirements of ANSI/ASQ E4-2004 and CIO 2106. Users are free to modify the worksheets as necessary to suit project-specific requirements; however all elements required by ANSI/ASQ E-4 and CIO 2106-G-05 must be addressed, or a satisfactory explanation must be provided for their exclusion. Table 1 provides a crosswalk between the worksheets and the respective elements of CIO 2106-G-05. In addition, each revised worksheet includes a reference to the appropriate CIO 2106-G-05 element.

It is emphasized that the final, approved QAPP is designed to be a stand-alone document containing all specifications and procedures necessary for project personnel to carry out their assigned responsibilities. For example, the field team should be able to rely on the QAPP for complete sampling instructions, including how to sample, where to sample, how many samples to collect, the types of bottles, preservatives, related QC, etc. If the approved QAPP provides insufficient procedures to carry out all tasks, then SOP’s must be attached to the QAPP. If required elements are contained in other documents, those documents may be referenced; however the documents must be available to all personnel responsible for reviewing and implementing the QAPP.

Page 5: Optimized UFP-QAPP Worksheets (PDF)

TABLE1. CROSSWALK: UFP-QAPP WORKBOOK TO 2106-G-05 QAPP

Optimized UFP-QAPP Worksheets 2106-G-05 QAPP Guidance Section

1 & 2 Title and Approval Page 2.2.1 Title, Version, and Approval/Sign-Off

3 & 5 Project Organization and QAPP Distribution 2.2.3 Distribution List

2.2.4 Project Organization and Schedule

4 , 7 & 8 Personnel Qualifications and Sign-off Sheet 2.2.1 Title, Version, and Approval/Sign-Off

2.2.7 Special Training Requirements and

Certification

6 Communication Pathways 2.2.4 Project Organization and Schedule

9 Project Planning Session Summary 2.2.5 Project Background, Overview, and Intended

Use of Data

10 Conceptual Site Model 2.2.5 Project Background, Overview, and Intended

Use of Data

11 Project/Data Quality Objectives 2.2.6 Data/Project Quality Objectives and

Measurement Performance Criteria

12 Measurement Performance Criteria 2.2.6 Data/Project Quality Objectives and

Measurement Performance Criteria

13 Secondary Data Uses and Limitations Chapter

3

QAPP ELEMENTS FOR EVALUATING EXISTING

DATA

14 & 16 Project Tasks & Schedule 2.2.4 Project Organization and Schedule

15 Project Action Limits and Laboratory-Specific

Detection / Quantitation Limits

2.2.6 Data/Project Quality Objectives and

Measurement Performance Criteria

17 Sampling Design and Rationale 2.3.1 Sample Collection Procedure, Experimental

Design, and Sampling Tasks

18 Sampling Locations and Methods 2.3.1 Sample Collection Procedure , Experimental

Design, and Sampling Tasks

2.3.2 Sampling Procedures and Requirements

19 & 30 Sample Containers, Preservation, and Hold

Times

2.3.2 Sampling Procedures and Requirements

20 Field QC 2.3.5 Quality Control Requirements

21 Field SOPs 2.3.2 Sampling Procedures and Requirements

22 Field Equipment Calibration, Maintenance,

Testing, and Inspection

2.3.6 Instrument/Equipment Testing, Calibration

and Maintenance Requirements, Supplies and

Consumables

23 Analytical SOPs 2.3.4 Analytical Methods Requirements and Task

Description

24 Analytical Instrument Calibration 2.3.6 Instrument/Equipment Testing, Calibration

and Maintenance Requirements, Supplies and

Consumables

Page 6: Optimized UFP-QAPP Worksheets (PDF)

Optimized UFP-QAPP Worksheets 2106-G-05 QAPP Guidance Section

25 Analytical Instrument and Equipment

Maintenance, Testing, and Inspection

2.3.6 Instrument/Equipment Testing, Calibration

and Maintenance Requirements, Supplies and

Consumables

26 & 27 Sample Handling, Custody, and Disposal 2.3.3 Sample Handling, Custody Procedures, and

Documentation

28 Analytical Quality Control and Corrective

Action

2.3.5 Quality Control Requirements

29 Project Documents and Records 2.2.8 Documentation and Records Requirements

31, 32 &

33

Assessments and Corrective Action 2.4 ASSESSMENTS AND DATA REVIEW (CHECK)

2.5.5 Reports to Management

34 Data Verification and Validation Inputs 2.5.1 Data Verification and Validation Targets and

Methods

35 Data Verification Procedures 2.5.1 Data Verification and Validation Targets and

Methods

36 Data Validation Procedures 2.5.1 Data Verification and Validation Targets and

Methods

37 Data Usability Assessment 2.5.2 Quantitative and Qualitative Evaluations of

Usability

2.5.3 Potential Limitations on Data Interpretation

2.5.4 Reconciliation with Project Requirements

Page 7: Optimized UFP-QAPP Worksheets (PDF)

Title: Revision Number:

Revision Date: Page 1 of 1

QAPP Worksheet #1 & 2: Title and Approval Page

(UFP-QAPP Manual Section 2.1)

(EPA 2106-G-05 Section 2.2.1)

This worksheet identifies the principal points of contact for all organizations having decision authority in

the project and documents their commitment to implement the QAPP. Signatories usually include the

lead organization’s Project Manager and QA Manager, and individuals with approval or oversight

authority from each regulatory agency. Signatures indicate that officials have reviewed the QAPP and

concur with its implementation it as written. If separate concurrence letters are issued, the original

correspondence should be maintained with the final, approved QAPP in the project file. It is the lead

organization’s responsibility to make sure all signatures are in place before work begins.

1. Project Identifying Information

a. Site name/project name

b. Site location/number

c. Contract/Work assignment number

2. Lead Organization

a. Lead Organization Project Manager (name/title/signature/date)

b. Lead Organization Quality Manager (name/title/signature/date)

3. Federal Regulatory Agency (name/title/signature/date)

4. State Regulatory Agency (name/title/signature/date)

5. Other Stakeholders (as needed)

6. List plans and reports from previous investigations relevant to this project

Page 8: Optimized UFP-QAPP Worksheets (PDF)

Title: Revision Number:

Revision Date: Page 1 of 1

QAPP Worksheet #3 & 5: Project Organization and QAPP Distribution

(UFP-QAPP Manual Section 2.3 and 2.4)

(EPA 2106-G-05 Section 2.2.3 and 2.2.4)

This worksheet identifies key project personnel, as well as lines of authority and lines of communication among the lead agency, prime contractor, subcontractors, and regulatory agencies. An example is provided below. For the purpose of the draft QAPP, it is permissible to show "TBD" in cases where roles have not been assigned; however, all key personnel must be identified in the final, approved QAPP. For the purpose of document control, this worksheet also can be used to document recipients of controlled copies of the QAPP. The draft QAPP, final QAPP, and any changes/revisions must be provided to all QAPP recipients shown on this chart. Use asterisks or other symbol to designate QAPP recipients. Contractors and subcontractors shown on this chart are responsible for document control within their organizations. *QAPP recipient Lines of authority _________________ Lines of Communication _________________

Page 9: Optimized UFP-QAPP Worksheets (PDF)

QAPP Worksheet #4, 7 & 8: Personnel Qualifications and Sign-off Sheet

(UFP-QAPP Manual Sections 2.3.2 – 2.3.4) (EPA 2106-G-05 Section 2.2.1 and 2.2.7)

This worksheet is used to identify key project personnel for each organization performing tasks defined in this QAPP. In this example, organizations include the prime contractor and laboratory. Add spaces for addition organizations and personnel as needed. This worksheet lists individuals’ project titles or roles; qualifications; and any specialized/non-routine training, certifications, or clearances required by the project, e.g., explosives and ordnance disposal (EOD) technician, Professional Engineer, Certified Professional Geologist, etc. ORGANIZATION:

Name Project Title/Role Education/Experience Specialized Training/Certifications

Signature/Date

ORGANIZATION:

Name Project Title/Role Education/Experience Specialized Training/Certifications

Signature/Date

*Signatures indicate personnel have read and agree to implement this QAPP as written

Title: Revision Number:

Revision Date: Page 1 of 1

Page 10: Optimized UFP-QAPP Worksheets (PDF)

Title: Revision Number:

Revision Date: Page 1 of 1

QAPP Worksheet #6: Communication Pathways

(UFP-QAPP Manual Section 2.4.2)

(EPA 2106-G-05 Section 2.2.4)

This worksheet should be used to document specific issues (communication drivers) that will trigger the need to communicate with other project

personnel or stakeholders. Its purpose is to ensure there are procedures in place for providing the appropriate notifications and generating the

appropriate documentation when handling important communications, including those involving regulatory interfaces, unexpected events,

emergencies, non-conformances, and stop-work orders. Examples are provided below; additional drivers may be added as needed.

Communication Driver Organization Name Contact

Information Procedure

(timing, pathway, documentation, etc.)

Page 11: Optimized UFP-QAPP Worksheets (PDF)

Title: Revision Number:

Revision Date: Page 1 of 1

QAPP Worksheet #9: Project Planning Session Summary

(UFP-QAPP Manual Section 2.5.1 and Figures 9-12)

(EPA 2106-G-05 Section 2.2.5)

A copy of this worksheet should be completed for each project planning session, whether sessions are

internal (project teams only) or external (includes regulators and/or stakeholders). It is used to provide a

concise record of participants, key decisions or agreements reached, and action items. Depending on the

stage of planning, project-planning sessions should involve key technical personnel as needed. Scoping

sessions can be by phone, web-conferencing, and/or face-to-face meeting depending upon logistical

considerations. Previous meeting minutes can be included as attachments if necessary and referenced.

Users may find it helpful to have copies of worksheets on hand for all planning sessions, in whatever

state of completion they may be. However, worksheets 10, 11, 15, and 17 should be prioritized in the

early stages of project planning. The following template may be modified to suit both the project and

the specific planning session.

Date of planning session:

Location:

Purpose:

Participants:

Name Organization Title/Role Email/Phone

Notes/Comments:

Consensus decisions made:

Action Items:

Action Responsible Party Due Date

Page 12: Optimized UFP-QAPP Worksheets (PDF)

Title: Revision Number:

Revision Date: Page 1 of 1

QAPP Worksheet #10: Conceptual Site Model

(UFP-QAPP Manual Section 2.5.2)

(EPA 2106-G-05 Section 2.2.5)

This worksheet is used to present the project’s conceptual site model (CSM). The CSM is a tool to assist

in the development of DQOs. The CSM uses primarily text and/or figures but may also include tables to

convey succinctly what is currently known about the site, and it should be updated as new data are

collected. As with the QAPP in general, the level of detail in the CSM should be based on the graded

approach. If an investigation includes multiple sites with unique characteristics or problems to be

addressed, then a separate CSM should be prepared for each site.

The CSM should include the following information:

Background information, i.e., site history (unless this information is presented in an Executive Summary)

Sources of known or suspected hazardous waste;

Known or suspected contaminants or classes of contaminants;

Primary release mechanism;

Secondary contaminant migration;

Fate and transport considerations;

Potential receptors and exposure pathways;

Land use considerations;

Key physical aspects of the site (e.g., site geology, hydrology, topography, climate); and

Current interpretation of nature and extent of contamination to the extent that it will influence project-specific decision-making.

Data gaps and uncertainties associated with the CSM need to be clearly identified.

Page 13: Optimized UFP-QAPP Worksheets (PDF)

Title: Revision Number:

Revision Date: Page 1 of 2

QAPP Worksheet #11: Project/Data Quality Objectives

(UFP-QAPP Manual Section 2.6.1)

(EPA 2106-G-05 Section 2.2.6)

This worksheet is used to develop and document project quality objectives (PQOs) or data quality

objectives (DQOs) using a systematic planning process (SPP). Examples of SPP include: 1) the DQO

Process1, and 2) the U.S. Army Corps of Engineers’ Technical Planning Process (TPP)2. The type of SPP

used will vary based on the graded approach. This worksheet is mainly populated as text although some

diagrams that capture decision processes are recommended. Regardless of the SPP applied, the QAPP

must document the environmental decisions that need to be made and the level of data quality needed

to ensure that those decisions are based on sound scientific data. The following guidelines are based on

EPA’s 7-step DQO process.

1. State the Problem. The problem statement should be consistent with information contained in

the CSM (Worksheet #10).

2. Identify the Goals of the Study. Identify specific study questions and define alternative

outcomes. The goals for either decision or estimation problems should explain how the data will

be used to answer questions and choose among the stated alternatives. Characterizing the

“nature and extent of contamination” is a commonly stated but inappropriate study goal

because it is vague and not focused on potential outcomes.

3. Identify Information Inputs. Specify the types of data that are required to fill gaps in the CSM.

Explain in specific terms how all data will be used. In addition to analytical data, this could

include published information on geology, climate, population distributions, endangered

species, etc. Information inputs should be consistent with decisions made during project

scoping, as documented on Worksheet #9.

4. Define the Boundaries of the Study. Specify the target population and characteristics of interest,

define spatial /temporal limits and the scale of inference (i.e., which populations will be

represented by which data.) Developing the list of target analytes presents one of the greatest

opportunities for streamlining a project, as it can help avoid unnecessary costs associated with

not only sampling, but also analysis, data review, reporting and management. Target analytes

should be focused on specific constituents reasonably known or suspected to be present. The

list of target analytes should be based on data gaps in the CSM. Focusing the list of analytes also

provides better opportunities for optimizing method performance to best suit those analytes.

1 Guidance on Systematic Planning Using the Data Quality Objectives Process, U.S. EPA, EPA QA/G-4, February

2006. 2 Technical Project Planning Process, U.S. Army Corps of Engineers, EM 200-1-2, August 1998

Page 14: Optimized UFP-QAPP Worksheets (PDF)

Title: Revision Number:

Revision Date: Page 2 of 2

5. Develop the Analytic Approach. Define the parameter(s) of interest, specify the type of

inference (e.g., “samples from groundwater monitoring wells x, y, and z will represent potable

water at the site) and develop the logic for drawing conclusions from findings (i.e., which sample

results will be used to support which decisions.) For decision problems, these are expressed as

“if---then” statements, or decision rules, that link potential results with conclusions or future

actions. For estimation problems, specify the estimator and the estimation procedure.

6. Specify Performance or Acceptance Criteria. For projects that involve hypothesis testing (e.g.

presence or absence of contamination exceeding some threshold value) for decision-making,

this will involve specifying probability limits for decision errors. For estimations and other

analytic approaches (e.g. estimating the volume of groundwater or soil potentially requiring

remediation), this will involve the development of performance criteria (for new data being

collected) or acceptance criteria (for existing data being considered for use).

7. Develop the Detailed Plan for Obtaining Data. Worksheet #11 generally will briefly explain the

basis for the sampling design, and then refer to Worksheet #17 – Sample Design and Rationale,

for further details. Worksheets #19, 20, 24-28, and 30 will specify analysis design requirements.

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Title: Revision Number:

Revision Date: Page 1 of 1

QAPP Worksheet #12: Measurement Performance Criteria

(UFP-QAPP Manual Section 2.6.2)

(EPA 2106-G-05 Section 2.2.6)

This worksheet documents the quantitative measurement performance criteria (MPC) in terms of precision, bias, and sensitivity for both field

and laboratory measurements and is used to guide the selection of appropriate measurement techniques and analytical methods. MPC are

developed to ensure collected data will satisfy the PQOs or DQOs documented on Worksheet #11. A separate worksheet should be completed

for each type of field or laboratory measurement. For analytical methods, MPC should be determined for each matrix, analyte, and

concentration level. [Qualitative MPC (representativeness and comparability) should be addressed in the sample design, which is documented

on Worksheet #17.] If MPC are analyte-specific, include this detail in a separate table or modify this worksheet as necessary. An example is

provided below in blue text. The example is provided for illustration only – it should not be construed as guidance for establishing MPC.

Matrix:

Analytical Group or Method:

Concentration Level:

Data Quality Indicator (DQI) QC sample or measurement performance activity

Measurement Performance Criteria

Page 16: Optimized UFP-QAPP Worksheets (PDF)

Title: Revision Number:

Revision Date: Page 1 of 1

QAPP Worksheet #13: Secondary Data Uses and Limitations

(UFP-QAPP Manual Section 2.7)

(EPA 2106-G-05 Chapter 3: QAPP Elements For Evaluating Existing Data)

This worksheet should be used to identify sources of secondary data (i.e., data generated for purposes other than this specific project or data

pertinent to this project generated under a separate QAPP) and summarize information relevant to their uses for the current project. This

worksheet should be supplemented by text describing specifically how all secondary data will be used. The project team needs to carefully

evaluate the quality of secondary data (in terms of precision, bias, representativeness, comparability, and completeness) to ensure they are of

the type and quality necessary to support their intended uses. Secondary data can include the following: sampling and testing data collected

during previous investigations, historical data, background information, interviews, modeling data, photographs, aerial photographs,

topographic maps, and published literature. When evaluating the reliability of secondary data and determining limitations on their uses,

consider the source of the data, the time period during which they were collected, data collection methods, potential sources of uncertainty, the

type of supporting documentation available, and the comparability of data collection methods to the currently proposed methods. Examples are

provided below.

Data type Source Data uses relative to current project Factors affecting the reliability of data and

limitations on data use

Page 17: Optimized UFP-QAPP Worksheets (PDF)

Title: Revision Number:

Revision Date: Page 1 of 1

QAPP Worksheet #14/16: Project Tasks & Schedule

(UFP-QAPP Manual Section 2.8.2)

(EPA 2106-G-05 Section 2.2.4)

The QAPP should include a project schedule showing specific tasks, the person or group responsible for their execution, and planned start and

end dates. Options for presenting this information include the following template or a Gantt Chart can be attached and referenced. Examples of

activities that should be listed include key on-site and off-site activities. Any critical steps and dates should be highlighted.

Activity Responsible party Planned start date Planned completion

date Deliverable(s) Deliverable due date

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Title: Revision Number:

Revision Date: Page 1 of 1

QAPP Worksheet #15: Project Action Limits and Laboratory-Specific Detection/Quantitation Limits

(UFP-QAPP Manual Section 2.6.2.3 and Figure 15)

(EPA 2106-G-05 Section 2.2.6)

This worksheet should be completed for each matrix, analyte, analytical method, and concentration level (if applicable). Its purpose is to make

sure the selected analytical laboratory and method can provide accurate data (i.e., quantitative results with known precision and bias) at the

Project Action Limit (PAL). During the systematic planning process, identify target analytes, PALs, and the reference limits (e.g. regulatory limits

or risk-based limits) on which action limits are based. (If more than one set of reference limits are applicable, add additional columns.) Target

analytes that are critical to project-specific decision-making should be highlighted. Next, determine the matrix-specific quantitation limit goal.

The quantitation limit goal should be lower than the PAL by an amount determined the DQOs/PQOs. This information, along with the MPC

documented on Worksheet #12, should be used to select analytical methods and laboratories. Once the methods and laboratories have been

selected, the remaining columns should be completed with laboratory-specific information. Project teams need to keep in mind that the

laboratory-specific quantitation limit is usually determined in reagent water; therefore, the Project Quantitation Limit Goal (matrix-specific

quantitation limit) will be higher. Explanations should be provided in cases where the quantitation limit is greater than either the project

quantitation limit goal or the PAL. The laboratory must provide documentation that demonstrates precision and bias at the laboratory-specific

quantitation limit. The laboratory-specific quantitation limit cannot be lower than the lowest calibration standard for any given method and

analyte.

Matrix:

Analytical Method:

Concentration level (if applicable):

Analyte Project Action

Limit (PAL)

PAL Reference

Project Quantitation Limit

Goal

Laboratory-specific

quantitation limit1

Laboratory-specific

detection limit2

1 Define quantitation limit terminology used by the project/laboratory

2 Define detection limit terminology used by the project/laboratory

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Title: Revision Number:

Revision Date: Page 1 of 1

QAPP Worksheet #17: Sampling Design and Rationale

(UFP-QAPP Manual Section 3.1.1)

(EPA 2106-G-05 Section 2.3.1)

This worksheet should be used to describe the sampling design and the basis for its selection. This

worksheet will mainly consist of text. It documents the last step of the systematic planning process. If a

site consists of multiple areas to be sampled, a separate worksheet should be used for each.

There are two general types of sampling designs: 1) probability-based designs, which should be used

when statistical conclusions are required, and 2) judgmental designs, which are more applicable to help

refine conceptual site models when further study is planned, or to confirm previous findings, but which

usually do not provide sufficient basis on their own to support statistical conclusions. Advice on selecting

appropriate sample designs may be found in Chapter 2 of Guidance for Choosing a Sampling Design for

Environmental Data Collection, EPA QA/G-5s. Regardless of the type of design selected, this worksheet

should explain the basis for its selection. It also should describe the following:

1. The physical boundaries for the area under study (include maps or diagrams).

2. The time period being represented by the collected data.

3. The descriptions and basis for dividing the site into sampling areas (e.g., decision units, exposure

units, etc.) that support the decision statements documented on Worksheet #11.

4. The basis for the number and placement of samples within sampling areas.

5. If sample locations are specified in the QAPP, descriptions of how actual sample positions will be

located once in the field. (Include maps or diagrams).

6. If a sample cannot be collected where planned, the decision process for changing the location.

7. If sample locations will be determined in the field, the decision process for doing so.

8. Contingencies in the event field conditions are different than expected and could have an effect

on the sample design.

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Title: Revision Number:

Revision Date: Page 1 of 1

QAPP Worksheet #18: Sampling Locations and Methods

(UFP-QAPP Manual Section 3.1.1 and 3.1.2)

(EPA 2106-G-05 Section 2.3.1 and 2.3.2)

The primary value of this worksheet is as a completeness check for field personnel and auditors/assessors. It facilitates checks to make sure all

planned samples have been collected and appropriate methods have been used. Ideally, this worksheet should list each individual sample that is

planned to be collected, including field QC samples. Samples with common entries may be grouped but field QC samples and samples that are

unique must be listed separately. If a sample is being collected in increments, use only one line to identify the sample as it will be analyzed; there

is no need to list the increments separately. (If the increments are placed in separate containers to be combined in the laboratory, then each

container must be labeled.) If a project involves the collection of a large number of samples, however, it may be acceptable to list groups of

similar samples on a single row. Detailed sampling SOPs must be available to field personnel and should be included as an appendix to the QAPP

and referenced in this worksheet. The comments field can be used as a reminder to note any special sample handling required in the field and/or

GPS coordinates. A map with locations marked should be included. Use additional worksheets as necessary.

Sample ID Matrix1 Depth (ft BGS) Type Analyte/

Analytical Group Sampling SOP Comments

1Key: SS = surface soil, S = soil, SD = sediment, GW = groundwater, SW = surface water

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Title: Revision Number:

Revision Date:

Page 1 of 1

Page 1 of 2

QAPP Worksheet #19 & 30: Sample Containers, Preservation, and Hold Times

(UFP-QAPP Manual Section 3.1.2.2) (EPA 2106-G-05 Section 2.3.2)

The purpose of this worksheet is to serve as a reference guide for field personnel. It is also an aid to completing the Chain of Custody form and shipping documents. Complete this table for each laboratory used. If laboratory accreditation/certification is required for this project, the project team must verify that the laboratory maintains current accreditation/certification status for each analyte/matrix/method combination, as applicable, throughout its involvement with the project. If the accreditation expiration dates are the same for all entries then a global expiration date can be added at the top of the table as appropriate.

Laboratory (Name, sample receipt address, POC, e-mail, and phone numbers):

List any required accreditations/certifications:

Back-up Laboratory:

Sample Delivery Method:

Analyte/

Analyte Group

Matrix

Method/

SOP

Accreditation

Expiration Date

Container(s)

(number, size & type per

sample)

Preservation

Preparation

Holding Time

Analytical Holding

Time

Data Package

Turnaround

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QAPP Worksheet #20: Field QC Summary

(UFP-QAPP Section 3.1.1 and 3.1.2)

(EPA 2106-G-05 Section 2.3.5)

This worksheet provides a summary of the types of samples to be collected and analyzed for the project. Its purpose is to show the relationship

between the number of field samples and associated QC samples for each combination of analyte/analytical group and matrix. This worksheet is

also useful for informing the laboratory of the number of samples to expect and for preparing analytical cost estimates. The number and types of

QC samples should be based on project-specific DQOs, and this worksheet should be adapted as necessary to accommodate project-specific

requirements. Not all types of QC samples shown in the example below will be necessary for all projects. However, some projects may require

additional QC samples (e.g. proficiency testing samples), which can be listed in the “other” column.

Samples that are collected at different depths at the same location, and analyzed separately, should be counted as separate field samples. Even

if they are taken from the same container as the parent field sample, matrix spikes and matrix spike duplicates are counted separately, because

they are analyzed separately. If composite samples or incremental samples are being collected, include only the sample that will be analyzed;

subsamples and increments should not be listed separately; however, all containers making up the sample (as received by the laboratory) must

be labeled.

Matrix Analyte/Analytical

Group Field

Samples Field

Duplicates Matrix Spikes

Matrix Spike

Duplicates

Field Blanks

Equipment Blanks

Trip Blanks

Other Total #

analyses

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QAPP Worksheet #21: Field SOPs

(UFP-QAPP Manual Section 3.1.2)

(EPA 2106-G-05 Section 2.3.2)

This worksheet is intended for use to document the specific field procedures being implemented, which is important for measurement

traceability. The QAPP must contain detailed descriptions of procedures for all field activities, including sample collection; sample preservation;

equipment cleaning and decontamination; equipment testing, maintenance and inspection; and sample handling and custody. If these

procedures are included in existing SOPs, then the SOPs should be reviewed to make sure they are either 1) sufficiently prescriptive to be

implemented as written, or 2) modified as necessary for this project. If an SOP provides more than one procedure or option (for example, one

SOP covers the use of several different types of field equipment for the same procedure) this worksheet must note the specific option or

equipment being used.) Basic information about the SOPs should be provided in this table, and the SOPS themselves should be included in an

appendix to the QAPP. Field SOPs must be readily available to all field personnel responsible for their implementation. The QAPP must explain

any planned modifications to field SOPs. Modifications should be clearly noted on the SOPs themselves. The specific type(s) of SOP

modifications/deviations must be summarized in the comments column or a reference provided.

SOP # or reference

Title, Revision, Date, and URL (if available)

Originating Organization

SOP option or Equipment Type (if SOP

provides different options)

Modified for Project?

Y/N Comments

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QAPP Worksheet #22: Field Equipment Calibration, Maintenance, Testing, and Inspection

(UFP-QAPP Manual Section 3.1.2.4)

(EPA 2106-G-05 Section 2.3.6)

This worksheet should document procedures for calibrating, maintaining, testing, and/or inspecting all field equipment (e.g., tools, pumps, gauges, magnetometers, pH meters, water-level measurement devices, etc.). If these activities are documented in an SOP or manufacturer’s instructions, and the relevant SOP or instruction is attached, then the frequency, acceptance criteria and corrective action columns may be left blank. Note that all the information summarized in this worksheet should be recorded in the field notes/logs.

Field Equipment Activity SOP Reference

Title or position of responsible

person Frequency

Acceptance Criteria

Corrective Action

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QAPP Worksheet #23: Analytical SOP’s

(UFP-QAPP Manual Section 3.2.1)

(EPA 2106-G-05 Section 2.3.4)

This worksheet documents information about the specific sample preparation and analytical procedures to be used, which is important for

measurement traceability. Screening data are used for interim investigations and/or will not be used for final risk assessment or site assessment

decisions unless they have been confirmed with definitive procedures. SOPs for all sample preparation and analytical procedures must be

current and referenced whether these activities are performed in the field or in an off-site laboratory. If this information is not known at the

time the QAPP is being prepared (i.e., laboratory selection has not occurred), it is acceptable to enter “TBD” for the required information. This

worksheet must be completed, however, before the QAPP is approved. If required by the project, copies of the SOPs should be included as a

hardcopy or electronic appendix. The project team should review all SOPs to make sure they are either 1) sufficiently prescriptive to be

implemented as written or 2) modified as necessary for this project. If an SOP provides more than one procedure or option [e.g., extraction

procedures for analytes of different concentration levels (SW5035), sulfur cleanup options (SW3660), or derivatization techniques (SW8151)],

the specific option being implemented must be noted. This worksheet must summarize planned modifications to existing SOPs, and

modifications should be clearly noted on the copies of the SOPs themselves. All personnel responsible for implementing sample preparation and

analytical SOPs must have access to the specific SOPs they are using.

SOP # Title, Date, and URL (if available) Definitive or

Screening Data Matrix/Analytical Group

SOP Option or Equipment Type

‡Modified for Project?

Y/N

‡ A brief summary of project-specific SOP modifications must be provided on this worksheet or referenced.

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QAPP Worksheet #24: Analytical Instrument Calibration

(UFP-QAPP Manual Section 3.2.2)

(EPA 2106-G-05 Section 2.3.6)

This worksheet should be completed for all analytical instruments, whether used in the field or the laboratory. As appropriate to the instrument, calibration procedures should include tuning, initial calibration, calibration blank, initial calibration verification (second source), continuing calibration verification, linear dynamic range (ICP and ICP/MS only), and verification of detection and quantification limits (however defined.) See also Worksheet 15. If information for a specific procedure is provided in an SOP, and the SOP is attached, then this worksheet can reference the SOP and identify the responsible person.

Instrument Calibration

Procedure

Calibration

Range Frequency

Acceptance

Criteria

Corrective

Action (CA)

Title/position

responsible for

Corrective Action

SOP

Reference

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QAPP Worksheet #25: Analytical Instrument and Equipment Maintenance, Testing, and Inspection

(UFP-QAPP Manual Section 3.2.3) (EPA 2106-G-05 Section 2.3.6)

The project team should determine whether it is necessary to complete all fields in this table. For example, if the selected laboratory is operating under a quality system that conforms to ISO 17025:2005, then the activities documented in this table will be documented in the laboratory’s quality manual (however named). In this case, it may be acceptable to simply reference the quality manual (including revision number and date.) If the project has specific requirements that are different from those contained in the laboratory’s quality manual, however, this table should be completed for those items.

Instrument / Equipment

Maintenance Activity

Testing Activity

Inspection Activity

Frequency Acceptance

Criteria Corrective

Action

Title/position responsible

for corrective action

Reference

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QAPP Worksheet #26 & 27: Sample Handling, Custody, and Disposal (UFP-QAPP Manual Section 3.3)

(EPA 2106-G-05 Section 2.3.3)

This worksheet is used to document responsibilities for maintaining custody of samples from sample collection through disposal. Examples of forms, sample labels, and chain of custody documentation should be included as an attachment to the QAPP. The information in this worksheet table can be referenced to the appropriate SOP’s if they are attached to the QAPP.

Sampling Organization:

Laboratory:

Method of sample delivery (shipper/carrier):

Number of days from reporting until sample disposal:

Activity Organization and title or position of person

responsible for the activity SOP reference

Sample labeling

Chain-of-custody form completion

Packaging

Shipping coordination

Sample receipt, inspection, & log-in

Sample custody and storage

Sample disposal

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QAPP Worksheet #28: Analytical Quality Control and Corrective Action

(UFP-QAPP Manual Section 3.4 and Tables 4, 5, and 6)

(EPA 2106-G-05 Section 2.3.5)

The purpose of this worksheet is to ensure that the selected analytical methods are capable of meeting project-specific MPC, which are based on PQOs/DQOs). Complete a separate worksheet for each sampling technique, analytical method/SOP, matrix, and analytical group. If method/SOP QC acceptance criteria do not meet the project-specific MPC, the data obtained may be unusable for making reliable project decisions. In this case the project team should consider selecting an alternate method or modifying the method. The list of QC samples in this example is incomplete. See Section 2.2 of Part 2B of the UFP-QAPP QA/QC Compendium, the QA Matrix in Section 3.4, and Tables 4, 5, and 6 for further information and guidance on QC samples. Matrix: Analytical Group: Analytical Method/SOP:

QC Sample

Number/Frequency Method/SOP

Acceptance Criteria Corrective Action

Title/position of person

responsible for corrective

action

Project-Specific MPC

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QAPP Worksheet #29: Project Documents and Records

(UFP-QAPP Manual Section 3.5.1) (EPA 2106-G-05 Section 2.2.8)

This worksheet should be used to record information for all documents and records that will be generated for the project. It describes how information will be collected, verified, and stored. Its purpose is to support data completeness, data integrity, and ease of retrieval. Examples are provided in blue text.

Sample Collection and Field Records

Record Generation Verification Storage location/archival

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Project Assessments

Record Generation Verification Storage location/archival

Laboratory Records

Record Generation Verification Storage location/archival

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Laboratory Data Deliverables

Record VOCs SVOCs PCBs Pesticides Metals Other

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QAPP Worksheet #31, 32 & 33: Assessments and Corrective Action

(UFP-QAPP Manual Sections 4.1.1 and 4.1.2)

(EPA 2106-G-05 Section 2.4 and 2.5.5)

This worksheet is used to document responsibilities for conducting project assessments, responding to assessment findings and implementing

corrective action. Appropriately scheduled assessments (e.g., field sampling technical systems audits (TSA) at the beginning of sampling) allow

management to implement corrective action in a timely manner, thereby correcting nonconformances and minimizing their impact on

DQOs/PQOs. Assessment checklists should be included in the QAPP or referenced.

Assessments:

Assessment Type Responsible Party &

Organization Number/Frequency Estimated Dates

Assessment Deliverable

Deliverable due date

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Assessment Response and Corrective Action:

Assessment Type Responsibility for

responding to assessment findings

Assessment Response

Documentation

Timeframe for Response

Responsibility for Implementing

Corrective Action

Responsible for monitoring

Corrective Action implementation

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QAPP Worksheet #34: Data Verification and Validation Inputs (UFP-QAPP Manual Section 5.2.1 and Table 9)

(EPA 2106-G-05 Section 2.5.1)

This worksheet is used to list the inputs that will be used during data verification and validation. Inputs include planning documents, field records, and laboratory records. Data verification is a check that all specified activities involved in collecting and analyzing samples have been completed and documented and that the necessary records (objective evidence) are available to proceed to data validation. Data validation is the evaluation of conformance to stated requirements, including those in the contract, methods, SOPs and the QAPP. Examples of records subject to verification and validation are listed below. The actual inputs required should be based on the graded approach, as defined during project planning.

Item Description Verification

(completeness)

Validation (conformance to

specifications)

Planning Documents/Records

1

2

4

5

Field Records

6

7

8

9

10

11

12

13

14

15

Analytical Data Package

16

17

18

19

20

21

22

23

24

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Item Description Verification

(completeness)

Validation (conformance to

specifications)

25

26

27

28

29

30

31

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QAPP Worksheet #35: Data Verification Procedures

(UFP-QAPP Manual Section 5.2.2)

(EPA 2106-G-05 Section 2.5.1)

This worksheet documents procedures that will be used to verify project data. It applies to both field and laboratory records. Data verification is

a completeness check to confirm that all required activities were conducted, all specified records are present, and the contents of the records

are complete. As illustrated in the following example, verification often is performed at more than one step by more than one person.

Records Reviewed

Requirement Documents

Process Description Responsible Person,

Organization

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QAPP Worksheet #36

Data Validation Procedures

(UFP-QAPP Manual Section 5.2.2)

(EPA 2106-G-05 Section 2.5.1)

This worksheet documents procedures that will be used to validate project data. Data validation is an analyte and sample-specific process for

evaluating compliance with contract requirements, methods/SOPs, and MPC. The scope of data validation needs to be defined during project

planning because it affects the type and level of documentation required for both field and laboratory activities. If data validation procedures

are contained in an SOP or other document, the procedures should be referenced in this table and included as an attachment to the QAPP. The

example provided below makes use of terminology contained in Guidance for Labeling Externally Validated Laboratory Data for Superfund Use,

EPA 540-R-08-005, which was developed to promote the use of consistent terminology by external data reviewer to describe the scope and

content of data review activities. The validation code and label identifier table, as well as any checklists to be used should be attached to the

QAPP. Any data qualifiers to be applied by the data validator must be defined. Of particular importance, third party data validation should NOT

include the rejection of data (noted by the designation of the “R” data qualifier). Data validation should note when performance criteria are not

met but the final rejection of any data and their use is a decision reserved specifically for the project team.

Data Validator:

Analytical Group/Method:

Data deliverable requirements:

Analytical specifications:

Measurement performance criteria:

Percent of data packages to be validated:

Percent of raw data reviewed:

Percent of results to be recalculated:

Validation procedure:

Validation code (*see attached table):

Electronic validation program/version:

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Validation Code and Label Identifier Table (To be attached to the QAPP)

Validation Code* Validation Label Description/Reference

S1VE Stage 1 Validation Electronic EPA 540-R-08-005

S1VM Stage 1 Validation Manual

S1VEM Stage 1 Validation Electronic and Manual

S2aVE Stage 2a Validation Electronic

S2aVM Stage 2a Validation Manual

S2aVEM Stage 2a Validation Electronic and Manual

S2bVE Stage 2b Validation Electronic

S2bVM Stage 2b Validation Manual

S2bVEM Stage 2b Validation Electronic and Manual

S3VE Stage 3 Validation Electronic

S3VM Stage 3 Validation Manual

S3VEM Stage 3 Validation Electronic and Manual

S4VE Stage 4 Validation Electronic

S4VM Stage 4 Validation Manual

S4VEM Stage 4 Validation Electronic and Manual

NV Not Validated

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QAPP Worksheet #37: Data Usability Assessment

(UFP-QAPP Manual Section 5.2.3 including Table 12)

(EPA 2106-G-05 Section 2.5.2, 2.5.3, and 2.5.4)

This worksheet documents procedures that will be used to perform the data usability assessment. The data usability assessment is performed at

the conclusion of data collection activities, using the outputs from data verification and data validation. It is the data interpretation phase, which

involves a qualitative and quantitative evaluation of environmental data to determine if the project data are of the right type, quality, and

quantity to support the decisions that need to be made. It involves a retrospective evaluation of the systematic planning process, and, like the

systematic planning process, involves participation by key members of the project team. The data usability assessment evaluates whether

underlying assumptions used during systematic planning are supported, sources of uncertainty have been accounted for and are acceptable,

data are representative of the population of interest, and the results can be used as intended, with the acceptable level of confidence.

Identify personnel (organization and position/title) responsible for participating in the data usability assessment:

Describe how the usability assessment will be documented:

Summarize the data usability assessment process including statistics, equations, and computer algorithms that will be used to analyze the data:

Step 1 Review the project’s objectives and sampling design

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Step 2 Review the data verification and data validation outputs

Step 3 Verify the assumptions of the selected statistical method

Step 4 Implement the statistical method

Step 5 Document data usability and draw conclusions